Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease
Terminated
Mannkind Corporation
Phase 3
2009-03-01
Examine the effects of TI in combination with an anti-diabetic regimen including inhaled
insulin versus anti-diabetic treatment without inhaled insulin on lung function & pulmonary
safety
Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease
Terminated
Sanofi
Phase 3
2009-03-01
Examine the effects of TI in combination with an anti-diabetic regimen including inhaled
insulin versus anti-diabetic treatment without inhaled insulin on lung function & pulmonary
safety
Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes Mellitus
Completed
Mannkind Corporation
Phase 1
2015-06-01
Primary Objective:
To assess the dose-response pattern of the glucose consumption (GIR-AUC0-end) of 3 different
single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of subcutaneous
(SC) insulin lispro in a euglycemic clamp setting.
Secondary Objectives:
To assess the dose proportionality of insulin exposure (INS-AUClast) of 3 different single
doses of Afrezza inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a
euglycemic clamp setting.
To assess the pharmacodynamic (PD) characteristics of 3 different single doses of Afrezza
inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a euglycemic clamp
setting.
To assess the pharmacokinetic (PK) characteristics of 3 different single doses of Afrezza
inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a euglycemic clamp
setting.
To assess the safety and tolerability of 3 different single doses of Afrezza inhaled
Technosphere insulin.
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